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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012452-15
Device Problems Break (1069); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/24/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: (b)(4). Visual, dimensional and functional inspections were performed on the returned device. The reported difficulty to position was confirmed. Additionally, an inner member separation was noted at the proximal balloon marker. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The investigation was unable to determine a conclusive cause for the reported difficulty.
 
Event Description
It was reported that the procedure was to treat a lesion located in the non-tortuous, but heavily calcified right coronary artery. The 3. 75 x 15 mm nc trek could not be advanced on the guide wire. Another 3. 75 x 15 mm nc trek was able to advance on the same guide wire without issue and was used successfully. No adverse patient effects or clinically significant delay in the procedure were reported. No additional information was provided. Return device analysis revealed the inner member was separated; however, the outer member was still intact.
 
Manufacturer Narrative
(b)(4). On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues. Abbott vascular performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis. The root cause identification was complicated by the fact that users were describing multiple symptoms when reporting the complaints. To date, the frequency of worldwide reported events for difficulties removing the protective balloon sheath, inflation and deflation has reached an actionable limit, thus abbott vascular communicated the voluntary field action to the fda [medwatch # 2024168-2017-02310]. Corrective action has been implemented per site operating procedures. The product will continue to be trended. The abbott internal recall number is 2024168-3/14/2017-002-r.
 
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Brand NameNC TREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key5657704
MDR Text Key45289984
Report Number2024168-2016-03148
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Catalogue Number1012452-15
Device Lot Number50319G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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